Issued by
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Neurological Disorders and Stroke (NINDS), intend to promote an ongoing initiative by publishing a Funding Opportunity Announcement (FOA) to solicit new or renewal applications for Wellstone Muscular Dystrophy Cooperative Research Centers.

The NIH expects to make up to three Center awards in response to this upcoming FOA, contingent upon the scientific merit of the applications and availability of funds.

The NIH established this Centers of Excellence program in 2003 as part of an ongoing effort to enhance and intensify research on the muscular dystrophies. These Centers were described in the MD-CARE Act (Public Law 107-84 of 2001 and 110-361 of 2008), and were named in honor of the late Senator Paul D. Wellstone. The theme of each Center must focus on one or more of the muscular dystrophies, which include Duchenne, Becker, myotonic, facioscapulohumeral, limb-girdle, congenital, oculopharyngeal, Emery-Dreifuss and others.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in the summer of 2014 with an expected due date in fall of 2014.

This FOA will utilize the U54 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into translational and clinical muscular dystrophy research to consider organizing collaborative groups to prepare applications for this FOA. Successful applicants will foster the translation of new scientific findings and technological developments into novel treatments or other strategies for improving the lives of muscular dystrophy patients. Each Center should involve clinical research with direct interactions between researchers and muscular dystrophy patients. Appropriate clinical studies could include natural history studies, biomarker development, early stage clinical trials, patient-oriented studies that facilitate future trials, biopsychosocial studies, health services research, etc. Each Center may also contain basic and/or preclinical translational research, as long as efforts are directed toward the steps required for the development of therapies, including therapeutic target identification, characterization and validation; development of pharmacodynamic biomarkers and surrogate endpoints; animal model development and characterization; candidate therapeutic screening, optimization and FDA-required activities leading to an investigational new drug (IND) application. Applicants should propose multi-disciplinary and collaborative studies that will significantly accelerate progress toward effective treatments or other improvements in patients' lives. Research problems should require substantial collaborative efforts to solve, and thus are best carried out in a center setting. Each Center should have at least one core facility that shares its services or resources with the national or international muscular dystrophy research community, and another core that promotes the career development of junior researchers, as well as patient and community outreach activities. Centers supported through this FOA will participate in annual meetings with the other Centers in the program to promote communication and collaborations.